HIV InfectionsACCESSNCT06730555
Advancing Access to HIV/HCV Testing for People Who Inject Drugs (PWID)
A study testing ACCESS Intervention in people with HIV Infections, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of the ACCESS strategy: an organizational-level intervention that uses funding and practice facilitation to improve the organizational capacity of syringe services programs (SSPs) to implement routine, opt-out HIV and Hepatitis C (HCV) testing and linkage to care… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- ACCESS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2025to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SSPs must:
- be operating in an Ending the HIV Epidemic (EHE) or Centers for Disease Control and Prevention (CDC) determined vulnerable jurisdictions;
- serve at least 300 unique participants per year;
- not currently offer opt-out HIV/HCV testing;
- be capable and willing to prospectively collect aggregated, site-level data on the number of participants who are: i) offered HIV/HCV screening, ii) completed these tests, and iii) linked to care, as well as provide participant demographics;
- have key staff that consent to participate in study surveys, qualitative interviews and practice facilitation throughout the study.
Who cannot join
- SSPs must not:
- currently receive or have received Frontline Communities in the United States (FOCUS) funding;
- have already implemented opt-out HIV/HCV testing.
- currently participating in SAIA-SSP-HIV (NCT06025435)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project ACCESS: Advancing Access to HIV/HCV Testing Through Transformation in Syringe Services Programs: A Cluster Randomized Trial
The purpose of this study is to test the effectiveness of the ACCESS strategy: an organizational-level intervention that uses funding and practice facilitation to improve the organizational capacity of syringe services programs (SSPs) to implement routine, opt-out HIV and Hepatitis C (HCV) testing and linkage to care for people who inject drugs (PWID).
- Conditions
- HIV Infections
- Being tested
- ACCESS Intervention, Control Group
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCESS InterventionBehavioural
Participants will receive the ACCESS intervention with funding, consisting of up to 16 hours of practice facilitation per month in person and/or virtually. Practice facilitation is training and support on implementation of routine HIV/HCV screening.
Control GroupBehavioural
Participants will receive a link to the CDC compendium of evidence-based interventions for HIV prevention.
| Study group | Role | What they receive |
|---|---|---|
| ACCESS Group | Experimental | Participants in this group will receive the ACCESS intervention for up to 18 months Receives: Behavioral: ACCESS Intervention |
| Control Group | Active comparator | Participants in this group will receive a link to the CDC Compendium of Evidence-Based Interventions for up to 18 months. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of SSP participants reached
Number of total HIV/HCV tests completed divided by the number of unique individuals seen
Measured: up to 18 months
Adoption
Proportion of SSPs that have created an HIV/HCV opt-out testing policy
Measured: up to 6 months
Secondary outcomes (1)
Number of SSP participants reached after the intervention
Number of total HIV/HCV tests completed divided by the number of unique individuals seen
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start27 Jun 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Tyler Scott Bartholomew, University of Miami
- Investigators
- Tyler Bartholomew, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730555
- Sponsor's protocol ID
- 20240611
- Other IDs
- R01DA060462
- Acronym
- ACCESS
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ACCESS: Advancing Access to HIV/HCV Testing Through Transformation in Syringe Services Programs: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06730555
- Acronym / sponsor ID
- ACCESS / 20240611
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of the ACCESS strategy: an organizational-level intervention that uses funding and practice facilitation to improve the organizational capacity of syringe services programs (SSPs) to implement routine, opt-out HIV and Hepatitis C (HCV) testing and linkage to care for people who inject drugs (PWID).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACCESS Group | Experimental | Behavioral: ACCESS InterventionParticipants in this group will receive the ACCESS intervention for up to 18 months |
| Control Group | Active comparator | Behavioral: Control GroupParticipants in this group will receive a link to the CDC Compendium of Evidence-Based Interventions for up to 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- SSPs must:
Key exclusion criteria (4 listed)
- SSPs must not:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACCESS InterventionParticipants will receive the ACCESS intervention with funding, consisting of up to 16 hours of practice facilitation per month in person and/or virtually. Practice facilitation is training and support on implementation of routine HIV/HCV screening. | Behavioural | ACCESS Group |
| Control GroupParticipants will receive a link to the CDC compendium of evidence-based interventions for HIV prevention. | Behavioural | Control Group |
Primary outcome
Number of SSP participants reached
Time frame: up to 18 months
Number of total HIV/HCV tests completed divided by the number of unique individuals seen
Adoption
Time frame: up to 6 months
Proportion of SSPs that have created an HIV/HCV opt-out testing policy
1 secondary outcome
Number of SSP participants reached after the intervention
Time frame: up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler Bartholomew, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACCESS Intervention in people with HIV Infections, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SSP participants reached (time frame: up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.